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Director, Analytical Operations

United States - California - OceansideProcess/Product Development & OperationsRegular

Job Description

Specific Responsibilities:

  • Lead, coach, develop, and inspire a team of seven analysts and scientists
  • Coordinate and execute phase appropriate Critical Quality Attribute assessment studies
  • Collaborate with research for the selection of clinical candidate and developability studies
  • Collaborate with analytical and process development function for the execution of relevant studies necessary to support process development, process characterization and validation.
  • Plan and execute analytical characterization studies to support phase appropriate comparability studies and reference standard qualification
  • Write and review relevant sections of regulatory filings, and reports used as source documents
  • Perform critical data review, design the relevant studies and provide directions for troubleshooting and investigation.
  • Guide the execution of relevant forced degradation and isolation and characterization of product and process related impurities
  • Proactively engage in collaboration with internal and external stakeholders to incorporate good practice and industrial trend into analytical development and control strategies.
  • Explore, develop, acquire new technologies 
  • Serve as an analytical representative on pharmaceutical development project teams and provides comprehensive project analysis to senior management.
  • Partake in BAO leadership and work closely with the cross functional groups to achieve project and team strategic goals.

Essential Education, Experiences and Skills:

  • Ph.D. in Biological Sciences, Chemistry, Chemical engineering, Pharmaceutical Sciences, or relevant field with ≥ 15 years of industry experience.
  • Must have a proven track record in mass spectrometry, proteomics, and protein biochemistry
  • Broad and direct experience of managing a variety of analytical activities including characterization method development, reference standard, product characterization, comparability and CQA assessments.
  • Must have experience in authoring analytical sections of early and late stage regulatory filings
  • Must have a robust understanding of analytical operations and regulatory expectations
  • Be an effective communicator of ideas, project goals and results to team members across cross-functional roles/departments.
  • Be self-motivated and organized, ability to prioritize multiple projects and excellent problem-solving skills.
  • Must think critically and creatively.
  • Excellent communication skills (both verbal and technical) and strong interpersonal skills are required.
  • Innovative, proactive, and resourceful; committed to excellence, quality and continuous improvement.

Preferred Skills:

  • Track record of publications in peer reviewed journals and oral communications at relevant conferences a plus
  • Experience in several of the following fields is strongly desired: Analytical chemistry, biochemistry, biological Mass Spectrometry, high performance or ultra-performance liquid chromatography, electrophoretic separations, chemical and biophysical structural elucidation, and bioinformatics.